On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Reports received by the FDA indicate that patients with breast implants have a higher risk of developing the disease within the scar capsule adjacent to the implant. As of the latest medical device reports (MDRs), the Agency believes that 457 cases and nine deaths were due to BIA-ALCL. In its letter, FDA specifically calls out health care providers, asking them to report all confirmed cases of BIA-ALCL in patients with breast implants as well as rates they have experienced during practice to the FDA.
Background
In 2011, FDA was the first public health agency to identify and communicate a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). BIA-ALCL is a type of Anaplastic Large Cell Lymphoma that can develop following breast implants. This rare blood cancer is a type of non-Hodgkin’s lymphoma, or cancer of the cells of the immune system, and is not considered breast cancer. It can occur in many different parts of the body, including the lymph nodes and skin, in cis- and trans-gender women and men. It has been reported that half of the reported cases were diagnosed within seven to eight years.
At the time of discovery, very little information was provided about the disease, but over time, the FDA has strengthened its understanding. Today, data displays that BIA-ALCL occurs more frequently following the implementation of breast implants with textured rather than smooth surfaces. According to FDA, “the type of implant fill does not appear to be a risk factor for BIA-ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. To date, there has not been sufficient data to determine whether ALCL may be found more or less frequently in individuals with silicone-filled breast implants compared to individuals with saline-filled breast implants.”
Medical Device Reports
As of September 2018, the Agency had received a total of 660 BIA-ALCL related MDRs. The FDA reviewed the reports to remove duplicate reports and “to control for MDRs in which a BIA-ALCL diagnosis was confirmed by: a physician, positive pathology/cytology test results, or positive for biomarker CD30 and negative for biomarker ALK.” After the analysis, the data reflected 457 unique MDRs for BIA-ALCL and nine deaths which may be attributed to BIA-ALCL. FDA reports that “at the time of diagnosis, patients may have their original breast implants, or they may have had one or more replacements.” The agency also reports that the number is not definite to the entire span of cases in the United States.
The MDRs do not provide a patient’s history of breast implants, the reports only provide general information about the implant at the time of diagnosis. Due to the limited number of cases, the FDA emphasized the need for more information to better characterize ALCL in individuals with breast implants. The Agency emphasizes that MDRs are only valuable depending on the accuracy of data, and in the future, more data may be gathered to better understand the disease.
Ongoing Actions of FDA
The Agency has developed an ongoing plan to better collect and evaluate ALCL information. FDA will:
- Receive and review MDRs
- Review the current medical literature
- Exchange information with other U.S and international regulators and scientific experts
- Review data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE Registry)
- PROFILE collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL
- Review BIA-ALCL information that breast implant manufacturers include in the labeling information provided to patients and health care professionals
- Review information provided from on-going post-market studies
- Monitor adverse events from other real-world data (e.g. National Breast Implant Registry)
Current Advancements
Since 2016, there has been several major advancements in the description of the disease and treatment recommendations, including:
- BIA-ALCL was recognized by the World Health Organization as a unique form of ALCL
- Professional organizations such as the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information for physicians to better understand the disease to provide diagnosis and treatment
- Regulatory bodies outside the United States such as the Australian Therapeutic Goods Administration and the French National Agency for Medicines and Health Products Safety have issued communications on BIA-ALCL
Recommendations for Health Care Providers
The FDA provides several recommendations for health care providers, including the following:
- Provide patients with manufacturer’s labeling and other educational material prior to implantation. Ensure that they are aware of the benefits and risks of each implant
- Consider the possibility of BIA-ALCL when treating late onset, preimplant seroma. If BIA-ALCL is suspected, refer the case to a multidisciplinary team for evaluation
- To rule out BAI-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology test
- Develop a treatment plan in coordination with the patient’s multidisciplinary care team
- All confirmed cases should be reported to MedWatch and the PROFILE Registry
Are you in the process of developing an implant or other FDA-regulated medical device? We can help you achieve successful interactions with the FDA. To learn more about our services and how we can help get your device through the FDA, contact us today.
